BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELD 96 NTE

    MDR report key: 196386 · Received November 12, 1998

    Report

    Report Number
    196386
    Event Type
    Death
    Date Received
    November 12, 1998
    Date of Event
    October 19, 1998
    Report Date
    October 29, 1998
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO
    Product Code
    FPB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUDDEN INFANT DEATH DURING OR DIRECTLY AFTER INTRAVENOUS TUBING CHANGE. HYPERALIMENTATION INFUSION. EVENT UNDER INVESTIGATION. (PT'S WEIGHT STATED AS 1400 GM)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELD 96 NTE IV SET SAVER FILTER FPB PALL BIOMEDICAL PRODUCTS CO ELD 96 NTE *

    Patients

    Seq Age Sex Outcome Treatment
    1 9 DAY Death 1. SIMS DELTEC IV ADMINISTRATION SET.| 2. 3M 3100 INFUSION PUMPS.